phase i/ii trial of a malaria vaccine in adults living in the united states of america

Conditions: Plasmodium Falciparum Malaria

Summary: phase i/ii trial of a malaria vaccine, fmp011/as01b, in adults living in the united states of america.

* controlled challenge, phase i/iia wrair study. * healthy, malaria-naive adults aged 18 - 50 years. * 2 groups, 5 subjects in group a (10µg dose) and 13 subjects in group b(50µg dose). * control: none for immunization phase; infectivity controls for challenge and rechallenge phases. six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed. * vaccination schedule of 0, 1 months. * challenge of up to 13 subjects in group b. * contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine. * self-contained study. * duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge). * data collection will be by done onsite.

Eligibility criteria:
inclusion criteria: * a male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening. * written informed consent obtained from the subject before screening procedures. * free of obvious health problems as established by medical history and clinical examination before entering into the study.\* * available to participate for duration of study (approximately 15 months). * if the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal. * pass a comprehension assessment test. exclusion criteria: * prior receipt of an investigational malaria vaccine. * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period. * administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination. * chronic use of antibiotics with anti-malarial effects. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). * history of use of anti-malarial medication within 60 days prior to vaccination. * any history of malaria. * known exposure to malaria within the previous 12 months. * planned travel to malarious areas during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, including hiv infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child. * history of splenectomy. * acute disease at the time of enrollment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease. * seropositive for hepatitis b surface antigen. * seropositive for hepatitis c virus (antibodies to hcv). * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned. administration during the study period * pregnant or lactating female. * suspected or known current alcohol abuse as defined by the american psychiatric association in dsm iv. * chronic or active intravenous drug use. * history of severe reactions to mosquito bites as defined as anaphylaxis. * female who intends to become pregnant during the study. * any history of anaphylaxis in reaction to vaccination. * a clinical history of sickle cell disease or sickle cell trait. * any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.

Keywords: vaccine phase i/ii malaria liver stage antigen -1 falciparum malaria protein -11 as01b adjuvant